Questionnaire based gastroesophageal reflux disease (GERD ...
Questionnaire based gastroesophageal reflux disease (GERD ...
Questionnaire based gastroesophageal reflux disease (GERD ...
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Indian J Gastroenterol (May–June 2011) 30(3):108–117<br />
DOI 10.1007/s12664-011-0105-9<br />
REVIEWARTICLE<br />
<strong>Questionnaire</strong> <strong>based</strong> <strong>gastroesophageal</strong> <strong>reflux</strong> <strong>disease</strong><br />
(<strong>GERD</strong>) assessment scales<br />
V. Pratap Mouli & Vineet Ahuja<br />
Received: 7 December 2010 /Accepted: 15 June 2011 /Published online: 23 July 2011<br />
# Indian Society of Gastroenterology 2011<br />
Abstract <strong>Questionnaire</strong> <strong>based</strong> assessment scales for<br />
<strong>gastroesophageal</strong> <strong>reflux</strong> <strong>disease</strong> (<strong>GERD</strong>) have been<br />
utilized for assessment of the patient’s symptomatology,<br />
assessment of symptom severity and frequency, assessment<br />
of health-related quality of life and for assessment<br />
of response to treatment. A multitude of unidimensional<br />
and multidimensional questionnaires exist for making<br />
symptom assessment and monitoring quality of life in<br />
<strong>GERD</strong>. Many of the scales meet some of the parameters<br />
of an ideal evaluative <strong>GERD</strong> specific assessment instrument.<br />
Yet, there are certain shortcomings and challenges<br />
which are faced in development of <strong>GERD</strong> questionnaires.<br />
This review discusses the features of an ideal symptom<br />
assessment instrument, examines the strengths and<br />
weaknesses of currently available questionnaires.<br />
Keywords Diagnosis . Gastroesophageal <strong>reflux</strong> <strong>disease</strong> .<br />
Health-related quality of life . Treatment assessment<br />
The prevalence of <strong>gastroesophageal</strong> <strong>reflux</strong> <strong>disease</strong> (<strong>GERD</strong>)<br />
ranges from 10% to 30% in the population of Western<br />
countries [1]. There is paucity of data regarding the<br />
magnitude of the problem in India. A recent study has<br />
shown the prevalence of <strong>GERD</strong> to be 16.2% among the<br />
employees of a large tertiary hospital in North India [2].<br />
V. P. Mouli : V. Ahuja (*)<br />
Department of Gastroenterology and Human Nutrition,<br />
All India Institute of Medical Sciences,<br />
New Delhi 110 029, India<br />
e-mail: vineetahuja2004@gmail.com<br />
<strong>GERD</strong> as a <strong>disease</strong> entity has varied presentations. The<br />
symptoms may not correlate with the endoscopic picture.<br />
The patients may present as any of the following:<br />
1. typical heartburn and <strong>reflux</strong> symptoms with endoscopic<br />
evidence of mucosal injury<br />
2. symptoms of heartburn and <strong>reflux</strong> but a normal upper<br />
gastrointestinal endoscopy (UGIE)<br />
3. no esophageal <strong>reflux</strong> symptoms but evidence of<br />
mucosal injury on UGIE or<br />
4. atypical symptoms such as dyspepsia, cough, asthma, etc.<br />
So aptly the 2006 consensus meeting held at Montreal<br />
defined <strong>GERD</strong> as “a condition that develops when the<br />
<strong>reflux</strong> of stomach contents causes troublesome symptoms<br />
and/or complications” [3].<br />
Because of these diverse clinical manifestations, diagnosis<br />
of <strong>GERD</strong> is not easy or straightforward. Traditional<br />
diagnostic modalities such as barium swallow and endoscopy<br />
have a sensitivity of 10% to 50% [4] and 30% to 50%<br />
[5, 6] respectively. 24-h esophageal pH monitoring is also<br />
normal in 6%–15% of patients with abnormal symptom<br />
index and not commonly available [7]. So an objective gold<br />
standard diagnostic test is lacking. In the Indian setting, a<br />
study evaluating the diagnostic algorithm of <strong>GERD</strong> found<br />
that a combination of omeprazole challenge test, endoscopy<br />
and histology will identify all cases of <strong>GERD</strong> [8]. This<br />
study concluded that 24-h esophageal pH testing, despite<br />
being the gold standard, has no utility in routine clinical<br />
settings and hence its availability should be limited to<br />
tertiary care settings. The patients were recruited on the<br />
basis of symptom score evaluation (heartburn and/or<br />
regurgitation) highlighting the importance of symptom<strong>based</strong><br />
questionnaires in the diagnosis of this <strong>disease</strong>.
Indian J Gastroenterol (May–June 2011) 30(3):108–117 109<br />
Structured questionnaires for diagnosis of <strong>GERD</strong> have been<br />
formulated <strong>based</strong> on the patients’ history. As <strong>GERD</strong> is a<br />
chronic <strong>disease</strong>, assessment of quality of life is another<br />
important aspect of the <strong>disease</strong> evaluation. <strong>Questionnaire</strong><strong>based</strong><br />
evaluation has played an important role in clinical<br />
trials of <strong>GERD</strong>. This has been so because symptom<br />
improvement and improvement of health-related quality of<br />
life (HRQOL) are the main goals of treatment of <strong>GERD</strong>.<br />
The aim of this review is to discuss the features of an<br />
ideal symptom assessment instrument, and to examine the<br />
strengths and weaknesses of currently available questionnaires.<br />
The utility of questionnaires in <strong>GERD</strong> has been<br />
found in the following settings:<br />
1. assessment of the patient’s symptoms<br />
2. assessment of symptom severity and frequency<br />
3. assessment of HRQOL<br />
4. assessment of response to treatment<br />
For achieving these objectives the questionnaires<br />
should be:<br />
1. sensitive to diagnose the <strong>disease</strong><br />
2. easily scored<br />
3. easily understandable<br />
4. easily translatable to local languages<br />
5. able to evaluate the <strong>disease</strong> as completely as possible,<br />
covering all types of typical and atypical symptoms<br />
6. able to assess changes with therapy over shorter as well<br />
as longer duration<br />
7. self reported/self administered<br />
8. economical<br />
9. psychometrically validated in clinical trials<br />
The questionnaires may be classified into - a) symptom<br />
assessing questionnaires (Table 1), b) health-related quality<br />
of life assessing questionnaires (Table 2), and c) hybrid<br />
questionnaires which assess symptom response as well as<br />
quality of life (Table 3). The symptom assessing questionnaires<br />
are either specific to <strong>GERD</strong> or wide covering other<br />
allied GI <strong>disease</strong>s.<br />
Symptom assessment scales in <strong>GERD</strong><br />
Symptom scales used for diagnosis of <strong>GERD</strong><br />
Greatorex and Thorpe [9] developed the esophageal<br />
symptom questionnaire to assist the diagnosis of <strong>GERD</strong>.<br />
It contained six items namely heartburn, regurgitation,<br />
dysphagia, bleeding, dyspepsia and vomiting, which were<br />
scored on a 4-point adjectival scale; the questionnaire was<br />
completed by the patient in the presence of the examining<br />
doctor. They found that the questionnaire was valid, but<br />
reliability and responsiveness were not assessed.<br />
Table 1 Scales for symptom assessment in <strong>gastroesophageal</strong> <strong>reflux</strong><br />
<strong>disease</strong> (<strong>GERD</strong>)<br />
<strong>GERD</strong> specific<br />
<strong>GERD</strong> specific esophageal symptom questionnaire [9]<br />
<strong>GERD</strong> specific questionnaire by Mold et al. [10]<br />
<strong>GERD</strong> specific questionnaire by Räihä et al. [11]<br />
<strong>GERD</strong> questionnaire [12]<br />
Infant <strong>gastroesophageal</strong> <strong>reflux</strong> questionnaire (I-GERQ) [13]<br />
Gastroesophageal <strong>reflux</strong> questionnaire (GERQ) [14]<br />
<strong>GERD</strong> Activity Index (GRACI) [15]<br />
<strong>GERD</strong> specific questionnaire by Carlsson et al. [16]<br />
<strong>GERD</strong> specific questionnaire by Manterola et al. [17]<br />
<strong>GERD</strong> score [18]<br />
<strong>GERD</strong> Symptom Assessment Scale (GSAS) [19]<br />
<strong>GERD</strong> screener [20]<br />
<strong>Questionnaire</strong> used by Vigneri et al. [21]<br />
Reflux <strong>disease</strong> diagnostic questionnaire (RDQ) [22]<br />
Chinese <strong>GERD</strong> <strong>Questionnaire</strong> (Chinese <strong>GERD</strong>Q) [23]<br />
Scores for assessment of other <strong>disease</strong>s along with <strong>GERD</strong><br />
Standardized esophageal symptom questionnaire [24]<br />
<strong>Questionnaire</strong> by Andersen et al. [25]<br />
Gastrointestinal Symptoms Rating Scale (GSRS) [26]<br />
<strong>Questionnaire</strong> by Ruth et al. [27]<br />
Ulcer esophagitis subjective symptoms scale (UESS) [28]<br />
Digestive health status instrument (DHSI) [29]<br />
Modified bowel <strong>disease</strong> questionnaire (BDQ) [30]<br />
Table 2 Scales for quality of life assessment in <strong>gastroesophageal</strong><br />
<strong>reflux</strong> <strong>disease</strong> (<strong>GERD</strong>)<br />
<strong>GERD</strong> specific<br />
Gastroesophageal <strong>reflux</strong> <strong>disease</strong> health-related quality of life<br />
(<strong>GERD</strong>-HRQL) [31]<br />
Heartburn - specific quality of life instrument (HBQOL) [32]<br />
<strong>GERD</strong> specific QoL questionnaire by Jasani et al. [33]<br />
QOL questionnaire in <strong>gastroesophageal</strong> <strong>reflux</strong> (Reflux-Qual) [34]<br />
Reflux-qual short-form (RQS) [35]<br />
Work Productivity and Activity Impairment <strong>Questionnaire</strong> for <strong>GERD</strong><br />
(WPAI-<strong>GERD</strong>) [36]<br />
QoL questionnaire for patients undergoing anti<strong>reflux</strong> surgery<br />
(QOLARS) [37]<br />
<strong>GERD</strong>-QOL [38]<br />
GI specific<br />
Gastrointestinal quality of life index (GIQLI) [39]<br />
Quality of life in <strong>reflux</strong> and dyspepsia (QOLRAD) [40]<br />
Patient assessment of upper gastrointestinal disorders (PAGI-QOL) [41]<br />
Generic<br />
Psychological general well-being index (PGWB) [42]<br />
EuroQoL-5 dimensions (EQ-5D) [43]<br />
36-Item short-form general health survey (SF-36) [44]
110 Indian J Gastroenterol (May–June 2011) 30(3):108–117<br />
Table 3 Hybrid scales assessing both symptoms and quality of life in<br />
<strong>gastroesophageal</strong> <strong>reflux</strong> <strong>disease</strong> (<strong>GERD</strong>)<br />
<strong>Questionnaire</strong>s by Colwell et al. [45] and Mathias et al. [46]<br />
HRQoL batteries [47]<br />
Domestic/International Gastroenterology Surveillance Study<br />
(DIGEST) [48]<br />
Reflux questionnaire (ReQuest) [49]<br />
Nocturnal <strong>GERD</strong> symptom severity and impact questionnaire<br />
(N-GSSIQ) [50]<br />
Johnsson et al. [12] used four structured and descriptive<br />
questions in their self reported <strong>GERD</strong> questionnaire. The<br />
description of symptoms rather than using the term heartburn<br />
may have been a factor in improving the predictive value of<br />
this questionnaire, but a positive response to all four questions<br />
was required to achieve a high positive predictive value, thus<br />
limiting its usefulness. Moreover, this questionnaire was<br />
specific for erosive <strong>GERD</strong> and/or patients with pathological<br />
pH values. This questionnaire was not validated.<br />
Ornstein et al. [13] devised a 138-item questionnaire to<br />
diagnose <strong>GERD</strong> in infants and to identify potentially<br />
provocative caretaking practices. In a validation study, it<br />
was shown that the questionnaire has high positive and<br />
negative predictive values for diagnosing <strong>GERD</strong>.<br />
Reidel et al. [24] assessed all patients referred over a<br />
one-year period for clinical esophageal manometry (not<br />
clear) by means of a self-reported questionnaire. Symptoms<br />
assessed were chest pain, dysphagia for solids and liquids,<br />
heartburn, regurgitation. They found esophageal symptoms<br />
to be poor predictors of manometric findings. However the<br />
questionnaire was not validated.<br />
Carlsson et al. [16] used word pictures of symptoms to<br />
design a self-assessment questionnaire that was intended to<br />
identify responders to PPI therapy. They found that the<br />
sensitivity of a scale increased whenever descriptions or word<br />
pictures were used instead of single terms. Prospective<br />
validation of this questionnaire in a primary care population<br />
did not find the questionnaire superior to the physician’s<br />
provisional diagnosis for discriminating omeprazole responders.<br />
The Digestive Health Status Instrument (DHSI) was<br />
designed as a self reported questionnaire incorporating 34<br />
items to assess functional gastrointestinal <strong>disease</strong>s related to<br />
bowel dysfunction/irritable bowel syndrome, <strong>reflux</strong>,<br />
dysmotility and pain in primary care settings [29].<br />
Psychometric analyses were performed and multiple types<br />
of reliability, validity and responsiveness were demonstrated<br />
in study populations including community, primary care<br />
and gastroenterology subjects [51].<br />
Symptom scales used for epidemiological studies of <strong>GERD</strong><br />
Mold et al. used a self reported <strong>GERD</strong> specific questionnaire<br />
with 15 items assessing <strong>GERD</strong> symptoms and<br />
pulmonary symptoms [10]. They found that 14% of elderly<br />
population had at least weekly heartburn and 24% of<br />
elderly population with alkaline <strong>reflux</strong> had pulmonary<br />
symptoms in contrast to none with acid <strong>reflux</strong>.<br />
Räihä et al. used a self reported <strong>GERD</strong> specific<br />
questionnaire designed in Finnish language to study the<br />
prevalence of <strong>GERD</strong> in elderly population [11]. The<br />
response rate and the completeness of the filling of forms<br />
were found to be high (~ 90%). They found that 54% of<br />
males and 66% of females among the elderly population<br />
had symptoms of <strong>GERD</strong> at least once a month. However<br />
both these questionnaires were not validated.<br />
Locke et al. developed a <strong>GERD</strong> specific self reported<br />
<strong>GERD</strong> questionnaire (GERQ) originally in English<br />
language [14]. They compared the symptoms assessed<br />
by this questionnaire with endoscopy findings and found<br />
that heartburn frequency was associated with esophagitis,<br />
the duration of acid regurgitation was associated with<br />
Barrett’s esophagus and strictures were associated with<br />
dysphagia severity and duration. However the questionnaire<br />
overall was only able to modestly predict endoscopic<br />
findings. The same questionnaire was later on translated<br />
into Spanish language and adapted to the Spanish<br />
population with good reproducibility and concurrent<br />
validity [52].<br />
Manterola et al. developed an observer reported questionnaire<br />
in Spanish language to study the prevalence of <strong>GERD</strong> in<br />
the general population [17]. Validation of this tool has been<br />
done in a further study and its usefulness was established<br />
[53]. However it’s performance and reliability if translated<br />
into English language was not further investigated.<br />
<strong>GERD</strong> screener is an interview <strong>based</strong> questionnaire<br />
assessing three subscales namely heartburn, regurgitation<br />
and medication use and the construct, convergent and<br />
predictive validity of this instrument were demonstrated<br />
[20]. This instrument was practical, short and easily<br />
administered and was intended to be used as a case finding<br />
tool in primary care settings and managed care organizations.<br />
Investigators from the All India Institute of Medical<br />
Sciences, New Delhi used a truncated scale (evaluated<br />
heartburn and regurgitation as a symptom score) originally<br />
developed by Vigneri et al. [21] (evaluated heartburn, pain<br />
and regurgitation as a symptom score) and found that a<br />
symptom score ≥4 had a high diagnostic accuracy for<br />
<strong>GERD</strong> [8]. This questionnaire was interview <strong>based</strong>. This<br />
validated score was then used to determine the prevalence<br />
of <strong>GERD</strong> among the employees of the same tertiary<br />
hospital [2]. This questionnaire was also used to diagnose<br />
<strong>GERD</strong> and then assess response to therapy in a randomized<br />
controlled trial [54]. The same scale was used in another<br />
population <strong>based</strong> cross-sectional study which intended to<br />
investigate the prevalence and risk factors of <strong>GERD</strong> in a<br />
high altitude area [55].
Indian J Gastroenterol (May–June 2011) 30(3):108–117 111<br />
Ho et al. modified the “Bowel Disease <strong>Questionnaire</strong><br />
(BDQ)” originally designed by Talley et al. [56] according<br />
to their local conditions and translated the English version<br />
into Chinese and Malay languages [30]. This questionnaire<br />
was interview <strong>based</strong> and used to assess various functional<br />
GI disorders. Prevalence of various GI symptoms with<br />
particular mention of <strong>reflux</strong>-type symptoms was assessed in<br />
a multiracial Asian population in Singapore. Feasibility,<br />
reproducibility and validity of the modified BDQ questionnaire<br />
were also demonstrated.<br />
Andersen et al. developed a self reported questionnaire<br />
in Danish language to detect benign esophageal <strong>disease</strong>s in<br />
epidemiological studies [25]. Ruth et al. developed a self<br />
reported questionnaire related to various esophageal<br />
<strong>disease</strong>s in Swedish language to assess the prevalence and<br />
severity of symptoms suggestive of esophageal <strong>disease</strong>s in<br />
a general population [27]. Both these questionnaires were<br />
neither translated and assessed in English language nor<br />
further validated.<br />
Symptoms scales to assess response to treatment<br />
<strong>GERD</strong> score is a symptom questionnaire developed to<br />
measure the outcome after the medical and surgical<br />
treatment of <strong>GERD</strong> [18]. This is a six item questionnaire<br />
administered by an external observer rather than being self<br />
reported. It is used to assess the severity (on a 4-point scale)<br />
and frequency (on a 5-point scale) of six <strong>GERD</strong> symptoms<br />
namely heartburn, regurgitation, epigastric or chest pain,<br />
epigastric fullness, dysphagia, cough by applying the scale<br />
to patients before and 6 months after treatment. This tool<br />
was validated psychometrically and shown to be reproducible,<br />
valid with significant correlation between the baseline <strong>GERD</strong><br />
score and lower esophageal sphincter pressure, 24-hr<br />
esophageal pH, and 8 subscales of the 36-item Short-Form<br />
General Health Survey (SF-36) and responsive to change.<br />
However this scale has certain limitations. It has not<br />
been validated for the assessment of short-term response<br />
of treatment of less than 6 months duration and the<br />
reproducibility over longer periods of time more than<br />
6 months has not been assessed. It doesn’t include<br />
atypical symptoms, is available only in English language<br />
and has to be administered by an external observer.<br />
Gastroesophageal Activity Index (GRACI) is a <strong>GERD</strong><br />
specific symptom scale developed by using multiple<br />
logistic regression analysis techniques to correlate clinical<br />
data with a physician’s assessment of <strong>GERD</strong> activity [15].<br />
The scale has a combination of interview <strong>based</strong> (12 items)<br />
and patient reported items (5 items noted in a diary daily for<br />
1 week). The questionnaire is available in English language<br />
and is administered at baseline and subsequently at 3-month<br />
intervals. The validity and reliability of the scale were<br />
demonstrated. It was developed as a major outcome<br />
variable in clinical trials. However it needs to be tested in<br />
further clinical trials as its responsiveness has not been<br />
proven conclusively.<br />
<strong>GERD</strong> Symptom Assessment Scale (GSAS) is a<br />
<strong>GERD</strong> specific self assessed scale available in English<br />
language and developed to be administered before and<br />
after treatment [19]. It has 15 items including various<br />
symptoms such as bloating, nausea, early satiety, etc.<br />
which usually are not included in other assessment tools.<br />
However it does not include all the atypical symptoms and<br />
nocturnal symptoms. It has been validated and shown to<br />
have acceptable reliability, content and construct validity<br />
and sensitive to changes in severity of symptoms and to<br />
changes over time.<br />
The Reflux Disease <strong>Questionnaire</strong> (RDQ) was originally<br />
developed to facilitate the diagnosis of <strong>GERD</strong> in primary<br />
care settings [22]. It is a self administered <strong>GERD</strong> specific<br />
questionnaire which assessed the frequency and severity of<br />
three parameters namely regurgitation, heartburn and<br />
dyspepsia. The validity, reliability and responsiveness of<br />
this scale have been demonstrated. In contrast to the<br />
original RDQ, a German version was created to assess<br />
treatment response for a period of 1 week [57]. Latter on in<br />
a study of 439 Scandinavian patients randomized to either<br />
esomeprazole or placebo, RDQ has been shown to be<br />
useful to evaluate treatment response [58]. The assessed<br />
time period is over the last 4 weeks at baseline and the last<br />
1 week period in patients being assessed for post-treatment<br />
benefit. This questionnaire was also shown to effectively<br />
differentiate various levels of patient-assessed symptom<br />
severity in comparision to physician-assessed severity of<br />
symptoms. The results were found to be consistent when<br />
the questionnaire was translated to Swedish and Norwegian<br />
languages.<br />
Madan et al. utilized the questionnaire developed to<br />
diagnose <strong>GERD</strong> in North Indian patients to assess response<br />
to therapy in a randomized controlled trial and found that a<br />
combination of pantoprazole and mosapride was more<br />
effective than pantoprazole alone in providing symptomatic<br />
relief to patients with erosive <strong>GERD</strong> [54].<br />
The Chinese <strong>GERD</strong> <strong>Questionnaire</strong> (Chinese <strong>GERD</strong>Q)<br />
[23] is a <strong>GERD</strong> specific, self reported instrument whose<br />
main framework is derived from the GERQ questionnaire<br />
[14]. Few additional questions <strong>based</strong> on the usual encountered<br />
clinical problems in their respective clinical settings<br />
were added to the original questionnaire and translated into<br />
Chinese language. The final questionnaire is usable in<br />
epidemiological studies and interventional studies of<br />
<strong>GERD</strong>. Content validity, construct validity, discriminant<br />
validity, reproducibility, test-retest reliability and internal<br />
consistency of the scale were demonstrated. However the<br />
questionnaire is available to be used only in Chinese<br />
language.
112 Indian J Gastroenterol (May–June 2011) 30(3):108–117<br />
The Ulcer Esophagitis Subjective Symptoms Scale is a<br />
self assessed and validated questionnaire with visual<br />
analogue scale for assessment of concerned dimensions in<br />
patients of peptic ulcer <strong>disease</strong> and esophagitis at baseline<br />
and after 4 weeks of treatment [28]. Thus this scale is not<br />
specific to <strong>GERD</strong>. It is available only in Swedish language.<br />
The Gastrointestinal Symptom Rating Scale (GSRS) was<br />
originally developed as a interview <strong>based</strong> tool to measure<br />
the outcomes for irritable bowel syndrome and peptic ulcer<br />
<strong>disease</strong> [59]. Later on it was modified to a self reported tool<br />
and extended for the assessment of <strong>GERD</strong> also [26]. Thus<br />
this scale is not <strong>GERD</strong> specific. It has 15 items combined<br />
into 5 symptom clusters namely <strong>reflux</strong>, abdominal pain,<br />
indigestion, diarrhea, constipation and scored on a 7-point<br />
Likert scale defined by verbal descriptors. It was made<br />
available for usage in many languages including English.<br />
Psychometric evaluation indicated that the 5 scales of the<br />
GSRS have good internal consistency, reasonable test-retest<br />
reliability, acceptable construct validity and it was proven to<br />
be responsive to treatment in clinical trials [60]. However<br />
the instrument was not found to be very sensitive for<br />
<strong>GERD</strong> [61].<br />
Quality of life assessment scales in <strong>GERD</strong><br />
HRQOL scales specific for <strong>GERD</strong><br />
The Gastroesophageal Reflux Disease Health-Related<br />
Quality of Life (<strong>GERD</strong>-HRQL) questionnaire is a self<br />
assessed, <strong>GERD</strong> specific scale devised in English language<br />
and is mainly used before and after anti-<strong>reflux</strong> surgery [31].<br />
It has 10 items scored on 6-point Likert scales addressing<br />
domains like severity of heartburn, conditions of heartburn,<br />
dysphagia, odynophagia, effect of medication and flatulence.<br />
But no extra-esophageal symptoms were included.<br />
This scale has been subjected to only limited psychometric<br />
evaluation. There was no significant correlation between<br />
the <strong>GERD</strong>-HRQL scores and the eight domains of the<br />
SF-36 scale [62].<br />
The Heartburn-specific Quality of Life instrument is a self<br />
assessed, patient diary <strong>based</strong>, <strong>GERD</strong> specific scale, available<br />
in English language and was developed to detect changes in<br />
HRQOL before and after <strong>GERD</strong> therapy in clinical trials [32].<br />
The questionnaire contains 15 items assessing 6 dimensions<br />
namely diet, mental health, pain, role physical, sleep and<br />
social activity. In a randomized controlled trial comparing<br />
ranitidine vs. placebo its responsiveness, reliability and<br />
validity were demonstrated [63]. However this scale has<br />
not been used widely in clinical trials.<br />
Jasani et al. devised a <strong>GERD</strong>-specific self-assessed<br />
HRQOL questionnaire consisting of 20 items [33]. But this<br />
scale was not subjected to psychometric evaluation.<br />
Raymond et al. developed a <strong>GERD</strong>-specific HRQOL<br />
questionnaire (Reflux-Qual) consisting of 37 items assessing<br />
7 dimensions including daily life, discomfort, wellbeing,<br />
physical functioning, anxiety, sleep, food by using<br />
5-point Likert scales [34]. The validity, reliability and<br />
responsiveness of this scale were demonstrated. However<br />
the validation has been performed only for the original<br />
French version of this scale, though it is available in various<br />
languages.<br />
The Reflux-Qual Short-Form measures the HRQOL in<br />
patients with <strong>GERD</strong> by assessing 5 domains including daily<br />
life, well-being, psychological impact, sleep and eating<br />
using 8 items by means of 5-point Likert scales [35]. It was<br />
devised for use in daily practice. Psychometric evaluation<br />
demonstrated good internal consistency, construct validity,<br />
reliability, discriminant validity and responsiveness. There<br />
was a good concurrent validity regarding the correlation<br />
between the SF-12 scores and the RQS score. However<br />
similar to the Reflux-Qual questionnaire, validation of this<br />
scale has also been performed only for the French version,<br />
though the scale has been translated and made available in<br />
various other languages.<br />
Work Productivity and Activity Impairment <strong>Questionnaire</strong><br />
for <strong>GERD</strong> (WPAI-<strong>GERD</strong>) is a self-assessed tool<br />
designed to assess absence from work, reduction in<br />
productivity and activities as measured in hours per day<br />
and in percent reduction respectively in patients of <strong>GERD</strong><br />
specifically [36]. The discriminant and convergent validity<br />
of the instrument have been demonstrated.<br />
The QOL questionnaire for patients undergoing Anti<strong>reflux</strong><br />
Surgery (QOLARS) was developed to assess HRQOL<br />
in <strong>GERD</strong> patients who underwent laparoscopic fundoplication<br />
[37]. The questionnaire consists of 45 items when<br />
administered preoperatively and 50 items when administered<br />
postoperatively and is devised in English language.<br />
The QOLARS questionnaire is a combination of the<br />
European Organization of Research and Treatment of<br />
Cancer quality of life questionnaire (EORTC-QLQ-C30)<br />
[64], the Visick score [65] and a modified <strong>GERD</strong>-HRQL<br />
[31]. All these scales have been validated. However the<br />
responsiveness of the QOLARS scale has not been reported<br />
clearly.<br />
Chan et al. developed the <strong>GERD</strong>-specific self-administered<br />
<strong>GERD</strong>-QOL questionnaire in Chinese language for multidimensional<br />
assessment of quality of life impairment because of<br />
<strong>GERD</strong> before and after treatment [38]. It is a pure HRQOL<br />
instrument with no symptom-specific questions. The final<br />
questionnaire had 16 items grouped into four subscales<br />
including daily activity, treatment effect, diet and psychological<br />
well-being assessed by a 5-point Likert scale. Psychometric<br />
validation was performed and internal consistency,<br />
test-retest reliability, construct validity, discriminant validity,<br />
responsiveness were demonstrated. The questionnaire was
Indian J Gastroenterol (May–June 2011) 30(3):108–117 113<br />
translated into English and linguistic validation was done.<br />
However the English version of the <strong>GERD</strong>-QOL questionnaire<br />
needs to validated further in English population and<br />
other ethnic groups to confirm its robustness for multiethnic<br />
studies.<br />
HRQOL scales specific for various GI <strong>disease</strong>s<br />
The Gastrointestinal Quality of Life Index (GIQLI) was<br />
developed to measure HRQOL in various GI <strong>disease</strong>s and<br />
not specific for <strong>GERD</strong> [39]. It is a system specific<br />
questionnaire assessing how frequently a symptom has<br />
interfered with the patients’ HRQOL during the past<br />
2 weeks. It consists of 36 items assessing 5 domains<br />
namely core symptoms, physical, emotional, social and<br />
<strong>disease</strong>-specific items and scoring is done on a 5-point<br />
Likert scale. The GIQLI scale has been validated in a<br />
variety of research settings. In the patients of <strong>GERD</strong>, it was<br />
shown to be responsive after anti<strong>reflux</strong> surgery. It is<br />
available and validated in various languages including<br />
English. The inability to discriminate between different GI<br />
<strong>disease</strong>s and that more than half the items in the<br />
questionnaire are related to the symptom frequency rather<br />
than HRQOL are the main limitations of this scale.<br />
The Quality of Life in Reflux and Dyspepsia (QOLRAD)<br />
scale is a self-assessed questionnaire developed to evaluate<br />
patients with <strong>GERD</strong> and dyspepsia [40]. It consists of 25<br />
items assessing the domains of emotional stress, sleep<br />
disturbance, food and drink problems, physical and social<br />
functioning and vitality. The degree of distress and frequency<br />
of the patients’ feelings during the last week are assessed by<br />
a 7-point Likert scale. Psychometric evaluation has been<br />
performed and the validity, reliability and responsiveness of<br />
this scale have been demonstrated. The QOLRAD scale<br />
showed a high concurrent validity when compared to the<br />
respective domains of the SF-36 or GSRS scales [40, 66]. It<br />
was validated and made available in various languages<br />
including English. Presence of more than one HRQOL<br />
domain in some of the subscales of this instrument may pose<br />
problems in clinical studies.<br />
The Patient Assessment of upper Gastrointestinal<br />
disorders (PAGI-QOL) has been designed to measure the<br />
HRQOL in patients of upper GI disorders [41]. The<br />
questionnaire can be either self-administered or interview<br />
administered and used to assess the patients’ HRQOL in the<br />
last 2 weeks. It consists of 30 items assessing 5 domains<br />
including daily activities, clothing, diet and food habits,<br />
relationship, and psychological well-being and distress with<br />
the scoring done on a 6-point Likert scale. Only the initial<br />
validation studies are available. It has ability to differentiate<br />
various GI disorders is yet to be demonstrated. It was<br />
translated and made available in many languages including<br />
English but validated in only few of them. Further<br />
validation studies in a broader population are needed for<br />
this instrument.<br />
Generic HRQOL scales<br />
The Psychological General Well-Being (PGWB) Index is a<br />
generic QOL instrument originally developed in healthy<br />
populations to measure subjective psychological well-being<br />
and distress [42]. It is a self-assessed questionnaire<br />
consisting of 22 items covering 6 dimensions of HRQOL<br />
including anxiety, depressed mood, positive well-being,<br />
self-control, general health and vitality, all these scored on a<br />
6-point Likert scale. It assesses the HRQOL over the last<br />
4 weeks. It has been shown to have excellent reliability and<br />
validity in studies of <strong>GERD</strong> and upper gastrointestinal<br />
<strong>disease</strong>s [42, 67]. It is useful for comparison when the<br />
construct validity and responsiveness of a new scale are<br />
tested. It is available, validated and being used in many<br />
languages and countries. That this scale doesn’t cover all<br />
the essential core domains of a HRQOL measure and<br />
instead focuses only on psychological or emotional<br />
domains and inability to distinguish between the underlying<br />
<strong>disease</strong>s are its limitations.<br />
The EuroQOL-5 Dimensions (EQ-5D) is a selfadministered<br />
questionnaire available worldwide and in<br />
many languages [43]. It was developed as a generic<br />
measure of health status and is useful in describing and<br />
evaluating HRQOL. However its main role is in generating<br />
cross-national comparisons for economic evaluations, thus<br />
it is useful for calculating quality-adjusted life years<br />
(QALYs) for pharmaco-economic studies. It is not considered<br />
to be a sensitive tool in <strong>disease</strong>-<strong>based</strong> outcome research.<br />
Adequate validation is not available for this scale.<br />
Thirty-six-Item Short-Form General Health Survey<br />
(SF-36) is a self-reported, generic HRQOL survey widely<br />
used in primary care settings and in various chronic <strong>disease</strong>s<br />
including <strong>GERD</strong> [44]. It consists of 8 domains covering<br />
physical function, role limitations - physical, bodily pain,<br />
vitality, general health perceptions, social functioning, role<br />
limitations - emotional, and mental health assessed by means<br />
of 36 items in the questionnaire. It has been demonstrated in<br />
various studies to have excellent reliability, content validity,<br />
construct validity and responsiveness [68]. It is available and<br />
validated in various languages including English. The<br />
standard SF-36 has a recall period of the last 4 weeks. A<br />
different version with a recall period of 1 week has also been<br />
developed to assess more rapid treatment effects. SF-36 is<br />
used to compare between subgroups of patients and across<br />
the general population. It has also been used as a gold<br />
standard in various studies done for validation of other<br />
HRQOL questionnaires. As the scale is generic and<br />
multipurpose, it is recommended that it be used with a more<br />
specific questionnaire while assessing the HRQOL in a
114 Indian J Gastroenterol (May–June 2011) 30(3):108–117<br />
particular <strong>disease</strong> [69]. However such an approach requires<br />
more manpower as well as is time consuming. Though more<br />
practicable versions like SF-12 and SF-20 have been<br />
developed, they have been used only in few studies as in<br />
the case of the former or not used at all as in the case of the<br />
SF-20 scale. Also the reliability and validity of the SF-12 are<br />
slightly lower compared to that of the SF-36, but sufficient<br />
for large sample studies [70].<br />
Hybrid scales assessing both symptoms and quality<br />
of life<br />
Colwell et al. [45] and Mathias et al. [46] developed an<br />
assessment tool for patients of erosive <strong>GERD</strong>, which<br />
measures quality of life as well as symptom frequency<br />
and distress, sleep problems, work disability and treatment<br />
satisfaction. It was shown to have acceptable reliability and<br />
validity. Another version of the same questionnaire is the<br />
HRQOL batteries developed to measure HRQOL in<br />
patients with symptomatic non-erosive <strong>GERD</strong> patients<br />
[47]. The HRQOL batteries questionnaire contains demographic<br />
items, two domains derived from the SF-12 namely<br />
physical component summary and mental component<br />
summary, six other domains assessing the frequency and<br />
bothersomeness of general <strong>GERD</strong> symptoms, symptoms<br />
related to eating, social restrictions, problems with sleep,<br />
work disability and treatment satisfaction. Psychometric<br />
evaluation has been done and the internal consistency,<br />
construct validity and responsiveness have been demonstrated.<br />
The correlations between the changes in HRQOL<br />
and change in heartburn symptoms were found to be low to<br />
moderate. Both these questionnaires are available in<br />
English.<br />
The Domestic/International Gastroenterology Surveillance<br />
Study (DIGEST) questionnaire was designed to determine the<br />
3 months prevalence of upper GI symptoms and the impact of<br />
these symptoms on HRQOL [48]. The questions in this<br />
instrument pertain to several gastrointestinal symptoms,<br />
socio-demographic data and quality of life for upper<br />
gastrointestinal <strong>disease</strong>s. The internal consistency and<br />
test-retest reliability have been demonstrated, but the<br />
responsiveness was not assessed. The main limitation of this<br />
scale is its length due to which it was not found to be<br />
conducive for routine use in clinical trials [71].<br />
ReQuest (Reflux <strong>Questionnaire</strong>) is a scale designed as<br />
a diary to be used by patients to quantify their total <strong>GERD</strong><br />
symptoms daily [49]. The frequency and intensity of seven<br />
dimensions namely acid complaints, upper abdominal/<br />
stomach complaints, lower abdominal/digestive complaints,<br />
nausea, sleep disturbances, other complaints and general<br />
well-being are assessed. A total of 67 symptom descriptions<br />
are incorporated in these seven dimensions. This questionnaire<br />
is self-administered and is available in 30 different<br />
languages. Two subscales of the ReQuest have been<br />
designed namely the ReQuest-GI and ReQuest-WSO,<br />
which measure symptoms traditionally associated with<br />
<strong>reflux</strong> and with general well-being, respectively, and permit<br />
these to be quantified and tracked independently. The<br />
ReQuest/LA-classification is developed by integrating<br />
the ReQuest-GI subscale with the modified Los Angeles<br />
scale used to grade esophagitis seen at endoscopy [72]. This<br />
tool allows both the symptoms and endoscopy appearances<br />
to be assessed in a single scale and thus complete remission<br />
of symptom relief as well as endoscopic healing can be<br />
identified. Such integrated indices help in standardization<br />
of clinical assessments and simplify comparison of results<br />
of different clinical trials. As minor degrees of <strong>reflux</strong> are<br />
common among healthy individuals, a ‘<strong>GERD</strong> symptom<br />
threshold’ has been calculated in a large population using<br />
ReQuest [73]. Recognizing this will help in targeting a<br />
more realistic end point in clinical trials rather than the<br />
difficult ‘complete absence’ of symptoms. For day-to-day<br />
clinical practice, a simplified version of the ReQuest has<br />
been devised and is referred to as ReQuest in Practice<br />
[74]. Psychometric evaluation and validation of ReQuest<br />
and its 2 subscales in both patients with erosive esophagitis<br />
[75] and nonerosive <strong>reflux</strong> <strong>disease</strong> [76] have demonstrated<br />
a high internal consistency, test-retest reliability, and<br />
responsiveness.<br />
Spiegel et al. developed and validated an instrument in<br />
English to assess the severity and impact of nocturnal<br />
symptoms of <strong>GERD</strong> [50]. The Nocturnal Gastroesophageal<br />
<strong>reflux</strong> <strong>disease</strong> symptom severity and impact<br />
questionnaire (N-GSSIQ) included 20 items and three<br />
subscales namely, nocturnal <strong>GERD</strong> symptoms, morning<br />
impact of nocturnal <strong>GERD</strong>, and concern about nocturnal<br />
<strong>GERD</strong>. The internal consistency, reliability and validity<br />
were demonstrated. The briefness of the questionnaire is an<br />
added advantage and it can be used either alone or in<br />
combination with other instruments for a more comprehensive<br />
assessment of patient-reported outcomes.<br />
Conclusions<br />
A multitude of unidimensional and multidimensional<br />
questionnaires exist for making symptom assessment and<br />
monitoring quality of life in <strong>GERD</strong>. Many of the scales<br />
meet some of the parameters of an ideal evaluative <strong>GERD</strong><br />
specific assessment instrument. Yet, there are certain shortcomings<br />
and challenges that are faced in development of<br />
<strong>GERD</strong> questionnaires. Primarily the development of the<br />
ideal assessment instrument is impeded by some of the<br />
inherent clinical features of <strong>GERD</strong>. There is no clear<br />
consensus regarding which symptoms constitute a diagnosis
Indian J Gastroenterol (May–June 2011) 30(3):108–117 115<br />
or how to define response to the treatment in managing<br />
patients with <strong>GERD</strong>. Furthermore, although many <strong>GERD</strong><br />
patients may manifest with typical symptoms, such as<br />
heartburn and acid regurgitation, others may predominantly<br />
complain of atypical symptoms, such as epigastric pain or<br />
pressure, nausea/vomiting, hoarseness, chest pain, and<br />
wheezing. The symptoms most often used for the diagnosis<br />
of <strong>GERD</strong> i.e. heartburn and regurgitation are highly specific<br />
(89% and 95%, respectively), but have low sensitivity<br />
(38% and 6%, respectively) leading to a trade-off while<br />
making a diagnostic assessment [5].<br />
The period of time that outcome measures are looked for<br />
is referred to as the time frame. This is prone to recall bias.<br />
One month is the maximum time frame which ensures a<br />
good balance between education of recall bias and having<br />
appropriate information on outcome measures [77].<br />
In summary, amongst the available assessment scales<br />
there is no perfect evaluative scale. In the last decade there<br />
has been significant progress in developing proper tools<br />
that provide better assessment of symptom change but the<br />
sensitivity to show daily alterations is not high. <strong>GERD</strong><br />
studies should utilize questionnaires <strong>based</strong> on unidimensional<br />
or multidimensional outcome measures that assess<br />
both symptom frequency and severity and have proven<br />
validity, reliability and responsiveness.<br />
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